Daré Bioscience and Theramex Announce Co-Development and Licensing Agreement for a Potential Biodegradable Long-Acting Contraceptive Implant

We are thrilled that Theramex selected Daré as its development partner for this potentially disruptive long-acting, minimally-invasive contraceptive candidate. The fully funded ongoing Phase 1 study is external validation of this important technology, and enables Daré and Theramex to make future development decisions based on results of the study. The in-license of these US patents to add to our portfolio is another example of how we leverage non-dilutive funding to advance first-in-category product candidates, and this collaboration with Theramex is a testament to our development track record in women’s health.

said Sabrina Martucci Johnson, President and CEO of Daré Bioscience.

We are excited to partner with Daré to develop Casea S, a potential first-in-category contraceptive candidate for women. A biodegradable implant for contraception resonates with what we hear from women as does the idea that she can make that choice every 18-24 months as to whether it is right for her. With its innovative design, Casea S would only require a single surgery visit, offering a more convenient, reversible alternative to existing long-acting contraceptive methods that would enable women to take control of their reproductive health with confidence.

said Rob Stewart, CEO of Theramex.

Casea S is designed to control release of a well-characterized contraceptive for a set period of time (18-24 months) before dissolving. It is designed to provide women with a long-acting, minimally-invasive contraceptive method that will not require surgical removal by a healthcare provider, which would improve convenience and could eliminate one of the barriers to use associated with existing implanted contraceptives.

FHI 360 is conducting a fully-funded Phase 1 trial to investigate pharmacokinetics, removability, safety and tolerability of Casea S with support from a foundation grant (ClinicalTrials.gov ID: NCT05174884).

Daré received a royalty-free, exclusive, fully paid up, sublicensable license to the US patents Theramex recently acquired for Casea S. Given that the product candidate is in an ongoing Phase 1 study that is funded by a grant, there are no development costs for Daré or Theramex at this time. If Daré determines that the results from the study are positive, it would be responsible for conducting the Phase II study in the US, and funding for such study and for a future Phase III study in the US will be shared by Daré and Theramex on terms to be agreed upon by the parties, taking into account the size of the opportunity for Casea S in their respective markets.